Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation

Summary

The COMACARE trial is a pilot multicenter randomized trial to assess the feasibility and effect on brain injury markers of targeting low or high normal arterial oxygen tension (PaO2), arterial carbon dioxide tension (PaCO2) and mean arterial pressure (MAP) in comatose, mechanically ventilated patients after out-of-hospital cardiac arrest. Using factorial design, participants are randomized at admission to intensive care unit to one of eight groups targeting either low or high normal values of PaO2, PaCO2 and MAP for 36 h. In this way, investigators will be assessing the feasibility and effect of all three variables at the same time.

The primary outcome is serum concentration of neuron-specific enolase (NSE) at 48 h after cardiac arrest. Feasibility outcome is between-group separation in PaO2, PaCO2 and MAP levels. Secondary outcomes include continuous monitoring of cerebral oxygenation, EEG and ECG for 48 h, the levels of NSE, S100B and cardiac troponin at randomization and 24, 48 and 72 h after cardiac arrest and neurological assessment at 6 months after cardiac arrest.

Conditions

• Out-of-Hospital Cardiac Arrest

Interventions

OTHER

Low normal PaCO2

4.5-4.7 kPa

OTHER

High normal PaCO2

5.8-6.0 kPa

OTHER

Low normal PaO2

10-15 kPa

OTHER

High normal PaO2

20-25 kPa

OTHER

Low normal MAP

65-75 mmHg

OTHER

High normal MAP

80-100 mmHg

Sponsors & Collaborators

• Laerdal Foundation

  collaborator OTHER

• The Finnish Medical Association

  collaborator OTHER

• Orion Research Foundation

  collaborator UNKNOWN

• Finnish Society of Anaesthesiologists

  collaborator UNKNOWN

• Helsinki University Central Hospital

  lead OTHER

Principal Investigators

• Matti Reinikainen, Associate Professor · Kuopio University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-22

Primary Completion

2017-11-03

Completion

2018-05-03

Countries

• Denmark
• Finland

Study Locations